Adjuvant EGFR-TKI Therapy

This prospective, multicenter patient registry is designed to evaluate the effectiveness and safety of postoperative EGFR tyrosine kinase inhibitor (EGFR-TKI) therapy in patients with completely resected EGFR-mutant high-risk stage IA2 to stage IIB non-small cell lung cancer. Approximately 100 adults aged 18 to 75 years will be enrolled across five participating centers. Eligible tumors must harbor an EGFR alteration, including exon 19 deletion, L858R, exon 20 insertion, or PACC mutations. High-risk stage IA2 disease is defined by at least one protocol-specified high-risk feature, including an invasive tumor component greater than 2 cm, lymphovascular invasion, a high-grade histologic pattern (at least 20% solid, micropapillary, cribriform, or complex glandular components), spread through air spaces, or sublobar resection. Postoperative management, including adjuvant EGFR-TKI therapy or observation, is determined by routine clinical practice and patient/physician preference rather than assigned by the study. Participants are categorized by EGFR mutation type into common sensitizing mutations (Group A) and uncommon/resistant mutations (Group B), with clinical stage used for stratified analyses. The primary outcome is disease-free survival (DFS). Secondary outcomes include 2-, 3-, and 5-year DFS rates, overall survival (OS), 5-year OS, health-related quality of life measured using the SF-36, and safety outcomes. Tumor tissue and serial blood samples are collected for genomic and exploratory biomarker analyses.